CHLORASEPTIC TOTAL SORE THROAT AND COUGH- menthol and benzocaine and dextromethorphan hydrobromide lozenge

Chloraseptic Total Sore Throat and Cough by

Drug Labeling and Warnings

Chloraseptic Total Sore Throat and Cough by is a Otc medication manufactured, distributed, or labeled by Prestige Brands Holdings, Inc., BestSweet, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

(in each lozenge)

Benzocaine 6 mg

Purpose

Oral Anesthetic/Analgesic

Active ingredients

(in each lozenge)

Dextromethorphan HBr 5 mg

Purpose

Cough Suppressant

Active ingredients

(in each lozenge)

Menthol 10 mg

Purpose

Oral Anesthetic/Analgesic

Uses

Temporarily relieves:

• occasional minor irritation, pain, sore throat and sore mouth
  
• cough due to minor throat and bronchial irritation as may occur with the common cold

Warnings

Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics.

Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 6 years of age unless directed by a doctor.

Do not use

this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, consult a health care professional before taking this product.

Ask a doctor before use if you have

• a persistent or chronic cough such as occurs with smoking, asthma, or emphysema 
  
• a cough is accompanied by excessive phlegm (mucus)

When using this product

do not exceed recommended dosage.

Stop use and ask a dentist or doctor if

• sore mouth symptoms do not improve in 7 days
  
• irritation, pain or redness persists or worsens
  
• swelling, rash or fever develops
  
• cough persists for more than 1 week, tends to recur, or is accompanied by a high fever, rash, or persistent headache. These could be symptoms of a serious condition.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• Adults and children over 12 years of age: 2 lozenges every 4 hours – not to exceed 12 lozenges every 24 hours.
  
• Children 6-12 years of age: 1 lozenge every 4 hours – not to exceed 6 lozenges every 24 hours.
  
• Children under 6 years of age: consult a doctor.

Other information

• Store between 59ºF and 86ºF (15ºC - 30ºC).
  
• Protect from moisture.
  
• Check expiration date before using.

Inactive ingredients

Corn Syrup, FD&C Blue no. 1, FD&C Red no. 40, Flavor, Glycerin, Soy Lecithin, Sucrose, Water

Questions?

1-800-552-7932 or www.chloraseptic.com

PRINCIPAL DISPLAY PANEL

Chloraseptic® Total SORE THROAT + COUGH Lozenges
Menthol/Benzocaine Oral Anesthetic/Analgesic
Dextromethorphan HBr Cough Suppressant
15 lozenges | Wild Cherry

INGREDIENTS AND APPEARANCE

CHLORASEPTIC TOTAL SORE THROAT AND COUGH 
menthol and benzocaine and dextromethorphan hydrobromide lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67172-016
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	6 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
CORN SYRUP (UNII: 9G5L16BK6N)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SUCROSE (UNII: C151H8M554)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	4mm
Flavor	CHERRY	Imprint Code	C
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67172-016-11	1 in 1 CARTON	08/01/2010
1		15 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	08/01/2010

Labeler - Prestige Brands Holdings, Inc. (159655021)

Establishment
Name	Address	ID/FEI	Business Operations
BestSweet, Inc.		002149136	MANUFACTURE(67172-016)